Guidewire navigation for sinuplasty

ABSTRACT

A method includes receiving image data, receiving surgical procedure data, and generating an operation plan. The image data is associated with anatomical structures in a nasal cavity of a patient. The image data and the surgical procedure data are received through a computing system. The act of generating an operation plan includes identifying a path for a surgical instrument in accordance with the image data and in accordance with the surgical procedure data. The act of generating the operation plan is performed through a computing system. The act of generating an operation plan further includes generating one or more instructional images depicting the identified path for the surgical instrument in a depiction of anatomical structures in the nasal cavity of the patient.

PRIORITY

This application claims priority to U.S. Provisional Patent App. No.62/022,607, Jul. 9, 2014, entitled “Guidewire Navigation forSinuplasty,” the disclosure of which is incorporated by referenceherein.

This application also claims priority to U.S. Provisional Patent App.No. 62/052,391, filed Sep. 18, 2014, entitled “Guidewire Navigation forSinuplasty,” the disclosure of which is incorporated by referenceherein.

JOINT RESEARCH STATEMENT

Subject matter disclosed in this application was developed and theclaimed invention was made by, or on behalf of, one or more parties to ajoint research agreement that was in effect on or before the effectivefiling date of the claimed invention. The claimed invention was made asa result of activities undertaken within the scope of the joint researchagreement. The parties to the joint research agreement include BiosenseWebster (Israel) Ltd. and Acclarent, Inc.

BACKGROUND

Image-guided surgery (IGS) is a technique where a computer is used toobtain a real-time correlation of the location of an instrument that hasbeen inserted into a patient's body to a set of preoperatively obtainedimages (e.g., a CT or MRI scan, three-dimensional map, etc.) so as tosuperimpose the current location of the instrument on the preoperativelyobtained images. In some IGS procedures, a digital tomographic scan(e.g., CT or MRI, three-dimensional map, etc.) of the operative field isobtained prior to surgery. A specially programmed computer is then usedto convert the digital tomographic scan data into a digital map ormodel. During surgery, instruments having sensors (e.g., electromagneticcoils that emit electromagnetic fields and/or are responsive toexternally generated electromagnetic fields) mounted thereon are used toperform the procedure while the sensors send data to the computerindicating the current position of each surgical instrument. Thecomputer correlates the data it receives from the instrument-mountedsensors with the digital map or model that was created from thepreoperative tomographic scan. The tomographic scan images are displayedon a video monitor along with an indicator (e.g., cross hairs or anilluminated dot, etc.) showing the real time position of each surgicalinstrument relative to the anatomical structures shown in the scanimages. In this manner, the surgeon is able to know the precise positionof each sensor-equipped instrument by viewing the video monitor even ifthe surgeon is unable to directly visualize the instrument itself at itscurrent location within the body.

Examples of electromagnetic IGS systems and associated instruments thatmay be used in ENT and sinus surgery include the InstaTrak ENT™ systemsavailable from GE Medical Systems, Salt Lake City, Utah. Other examplesof electromagnetic image guidance systems that may be modified for usein accordance with the present disclosure include but are not limited tothe CARTO® 3 System by Biosense-Webster, Inc., of Diamond Bar, Calif.;systems available from Surgical Navigation Technologies, Inc., ofLouisville, Colo.; and systems available from Calypso MedicalTechnologies, Inc., of Seattle, Wash.

Other examples of IGS related methods, devices, and/or systems that maybe modified for use in accordance with the teachings herein include butare not limited to those disclosed in U.S. Pat. No. 8,702,626, entitled“Guidewires for Performing Image Guided Procedures,” issued Apr. 22,2014, the disclosure of which is incorporated by reference herein; U.S.Pat. No. 8,320,711, entitled “Anatomical Modeling from a 3-D Image and aSurface Mapping,” issued Nov. 27, 2012, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,190,389, entitled“Adapter for Attaching Electromagnetic Image Guidance Components to aMedical Device,” issued May 29, 2012, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,123,722, entitled“Devices, Systems and Methods for Treating Disorders of the Ear, Noseand Throat,” issued Feb. 28, 2012, the disclosure of which isincorporated by reference herein; and U.S. Pat. No. 7,720,521, entitled“Methods and Devices for Performing Procedures within the Ear, Nose,Throat and Paranasal Sinuses,” issued May 18, 2010, the disclosure ofwhich is incorporated by reference herein.

Still further examples of IGS related methods, devices, and/or systemsthat may be modified for use in accordance with the teachings hereininclude but are not limited to those disclosed in U.S. Pat. Pub. No.2014/0364725, entitled “Systems and Methods for Performing Image GuidedProcedures within the Ear, Nose, Throat and Paranasal Sinuses,”published Dec. 11, 2014, the disclosure of which is incorporated byreference herein; U.S. Pat. Pub. No. 2014/0200444, entitled “Guidewiresfor Performing Image Guided Procedures,” published Jul. 17, 2014, thedisclosure of which is incorporated by reference herein; U.S. Pat. Pub.No. 2012/0245456, entitled “Adapter for Attaching Electromagnetic ImageGuidance Components to a Medical Device,” published Sep. 27, 2012, thedisclosure of which is incorporated by reference herein; U.S. Pat. Pub.No. 2011/0060214, entitled “Systems and Methods for Performing ImageGuided Procedures within the Ear, Nose, Throat and Paranasal Sinuses,”published Mar. 10, 2011, the disclosure of which is incorporated byreference herein; U.S. Pat. Pub. No. 2008/0281156, entitled “Methods andApparatus for Treating Disorders of the Ear Nose and Throat,” publishedNov. 13, 2008, the disclosure of which is incorporated by referenceherein; and U.S. Pat. Pub. No. 2007/0208252, entitled “Systems andMethods for Performing Image Guided Procedures within the Ear, Nose,Throat and Paranasal Sinuses,” published Sep. 6, 2007, the disclosure ofwhich is incorporated by reference herein.

In some instances, it may be desirable to use IGS guidance when dilatingan anatomical passageway in a patient. This may include dilation ofostia of paranasal sinuses (e.g., to treat sinusitis), dilation of thelarynx, dilation of the Eustachian tube, dilation of other passagewayswithin the ear, nose, or throat, etc. A system that may be used toperform such procedures may be provided in accordance with the teachingsof U.S. Pub. No. 2011/0004057, entitled “Systems and Methods forTransnasal Dilation of Passageways in the Ear, Nose or Throat,”published Jan. 6, 2011, the disclosure of which is incorporated byreference herein. An example of such a system is the Relieva® SpinBalloon Sinuplasty™ System by Acclarent, Inc. of Menlo Park, Calif.

A variable direction view endoscope may be used in conjunction with anIGS system during a dilation procedure to provide at least some degreeof direct visualization within the anatomical passageway (e.g., the ear,nose, throat, paranasal sinuses, etc.) to position the balloon atdesired locations. A variable direction view endoscope may enableviewing along a variety of transverse viewing angles without having toflex the shaft of the endoscope within the anatomical passageway. Suchan endoscope that may be provided in accordance with the teachings ofU.S. Pub. No. 2010/0030031, entitled “Swing Prism Endoscope,” publishedFeb. 4, 2010, the disclosure of which is incorporated by referenceherein. An example of such an endoscope is the Acclarent Cyclops™Multi-Angle Endoscope by Acclarent, Inc. of Menlo Park, Calif.

While a variable direction view endoscope and IGS system may be used toprovide visualization within the anatomical passageway, it may also bedesirable to provide additional visual confirmation of the properpositioning of the balloon before inflating the balloon. This may bedone using an illuminating guidewire. Such a guidewire may be positionedwithin the target area and then illuminated, with light projecting fromthe distal end of the guidewire. This light may illuminate the adjacenttissue (e.g., hypodermis, subdermis, etc.) and thus be visible to thenaked eye from outside the patient through transcutaneous illumination.Such an illuminating guidewire may be provided in accordance with theteachings of U.S. Pub. No. 2012/0078118, entitled “Sinus IlluminationLightwire Device,” published Mar. 29, 2012, the disclosure of which isincorporated by reference herein. An example of such an illuminatingguidewire is the Relieva Luma Sentry™ Sinus Illumination System byAcclarent, Inc. of Menlo Park, Calif.

When applied to functional endoscopic sinus surgery (FESS), balloonsinuplasty, and/or other ENT procedures, the use of an IGS allows thesurgeon to achieve more precise movement and positioning of the surgicalinstruments than can be achieved by viewing through an endoscope alone.This is so because a typical endoscopic image is a spatially limited,two-dimensional, line-of-sight view. The use of an IGS provides a realtime, three-dimensional view of all of the anatomy surrounding theoperative field, not just that which is actually visible in thespatially limited, two-dimensional, direct line-of-sight endoscopicview. As a result, an IGS may be particularly useful during performanceof FESS, balloon sinuplasty, and/or other ENT procedures, especially incases where normal anatomical landmarks are not present or are difficultto visualize endoscopically.

In addition to simply providing visual feedback to the surgeonindicating the position of instruments within a patient, it may bedesirable to use the equipment and software of an IGS system to providedetailed instructions to a surgeon. Such detailed instructions may bebased on the unique anatomy of the particular patient, as mapped ormodeled by the IGS system.

While several systems and methods have been made and used to perform ENTrelated surgical procedures, it is believed that no one prior to theinventors has made or used the invention described in the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a schematic view of an exemplary sinus surgery system;

FIG. 2 depicts a perspective view of the head of a patient, withcomponents of the sinus surgery system of FIG. 1;

FIG. 3A depicts a cross-sectional side view of an exemplary guidewirethat may be used with the sinus surgery system of FIG. 1;

FIG. 3B depicts a cross-sectional end view of the guidewire of FIG. 3A,taken along line IIIB-IIIB of FIG. 3A;

FIG. 4A depicts a cross-sectional side view of another exemplaryguidewire that may be used with the sinus surgery system of FIG. 1;

FIG. 4B depicts a cross-sectional end view of the guidewire of FIG. 4A,taken along line IVB-IVB of FIG. 4A;

FIG. 5A depicts a cross-sectional side view of another exemplaryguidewire that may be used with the sinus surgery system of FIG. 1;

FIG. 5B depicts a cross-sectional end view of the guidewire of FIG. 5A,taken along line VB-VB of FIG. 5A;

FIG. 6 depicts a flowchart showing steps of an exemplary process thatmay be performed using the sinus surgery system of FIG. 1;

FIG. 7 depicts a flowchart showing steps of an exemplary process thatmay be used to generate an operation plan for a surgical procedure;

FIG. 8 depicts a flowchart showing steps of another exemplary processthat may be used to generate an operation plan for a surgical procedure;

FIG. 9 depicts a flowchart showing steps of an exemplary process thatmay be used to render an operation plan for a surgical procedure to aphysician;

FIG. 10 depicts a superior axial cross-sectional view of a portion of ahuman head, showing paranasal sinus structures, that may be rendered asan instructional image in an operation plan for a surgical procedure;

FIG. 11 depicts a virtual endoscopic view of a middle meatus of a humanhead, with a representation of a guide catheter and guidewire, that maybe that may be rendered as an instructional image in an operation planfor a surgical procedure;

FIG. 12 depicts a virtual endoscopic view of a middle meatus of a humanhead, with a three-dimensional arrow, that may be that may be renderedas an instructional image in an operation plan for a surgical procedure;

FIG. 13A depicts a virtual endoscopic view of a middle meatus of a humanhead, with a first arrow of an animated series, that may be that may berendered as an instructional image in an operation plan for a surgicalprocedure;

FIG. 13B depicts a virtual endoscopic view of a middle meatus of a humanhead, with a second arrow of an animated series, that may be that may berendered as an instructional image in an operation plan for a surgicalprocedure;

FIG. 13C depicts a virtual endoscopic view of a middle meatus of a humanhead, with a third arrow of an animated series, that may be that may berendered as an instructional image in an operation plan for a surgicalprocedure; and

FIG. 14 depicts a schematic view of an exemplary system that may be usedto provide at least a portion of the processes of FIGS. 7-9.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “top” and “bottom” also are usedherein with respect to the clinician gripping the handpiece assembly.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

It is further understood that any one or more of the teachings,expressions, versions, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, versions,examples, etc. that are described herein. The following-describedteachings, expressions, versions, examples, etc. should therefore not beviewed in isolation relative to each other. Various suitable ways inwhich the teachings herein may be combined will be readily apparent tothose of ordinary skill in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

I. Exemplary Image Guided Surgery System

FIG. 1 shows an exemplary sinus surgery system (20) while FIG. 2 showsthe head of a patient (22) undergoing surgery with system (20). In thepresent example, system (20) is used during a sinuplasty procedure onthe patient (22), though it should be understood that system (20) may bereadily used in various other kinds of procedures. In the presentexample, before the sinuplasty procedure begins, a set of magnetic fieldgenerators (24) are fixed to the head of the patient (22). Fieldgenerators (24) are incorporated into a frame (26), which is clamped tothe head of the patient (22). As is explained below, field generators(24) enable tracking of the position of a guidewire (28) that isinserted into the nasal sinus of the patient (22). While fieldgenerators (24) are secured to the head of the patient (22) in thisexample, it should be understood that field generators (24) may insteadbe positioned at various other suitable locations and on various othersuitable structures. By way of example only, field generators (24) maybe mounted on an independent structure that is fixed to a table or chairon which the patient (22) is positioned, on a floor-mounted stand thathas been locked in position relative to the head of the patient (22),and/or at any other suitable location(s) and/or on any other suitablestructure(s).

Elements of system (20), including field generators (24), are controlledby a system processor (40) in this example. Processor (40) comprises aprocessing unit communicating with one or more memories. Processor (40)of the present example is mounted in a console (50), which comprisesoperating controls (51) that include a keypad and/or a pointing devicesuch as a mouse or trackball. Console (50) also connects to otherelements of system (20), such as a proximal end (52) of guidewire (28).A physician (54) uses the operating controls to interact with processor(40) while performing the procedure. Also during the procedure,processor (40) presents results produced by system (20) on a screen(56).

Processor (40) uses software stored in a memory of the processor tooperate system (20). The software may be downloaded to processor (40) inelectronic form, over a network, for example, or it may, alternativelyor additionally, be provided and/or stored on non-transitory tangiblemedia, such as magnetic, optical, or electronic memory. Processor (40)uses the software, inter alia, to operate and calibrate field generators(24). Field generators (24) are operated so as to transmit alternatingmagnetic fields of different frequencies into a region in proximity toframe (26). Prior to being placed on the patient (22), field generators(24) in frame (26) may be calibrated by positioning a coil (not shown)in the region in known locations and orientations relative to frame(26). Signals are induced in the calibration coil by the alternatingmagnetic fields, and processor (40) acquires and records the signals.Processor (40) then formulates a calibration relationship between thelocations and orientations of the calibration coil, and the recordedsignals for these locations and orientations.

Once the calibration relationship has been formulated, frame (26) may beplaced on the head of the patient (22). Alternatively, as noted above,some versions may provide field generators (24) on structures other thanframe (26). In the present example, however, after frame (26) has beenplaced on the head of the patient (22), frame (26) is fixed in positionand registered with external features of the head of the patient (22),for example by imaging the head of the patient (22) with the attachedframe (26) from a number of different angles. The frame (26)registration also registers the field generators (26) with the externalfeatures of the patient (22). Alternatively or additionally, theregistration may include placing a coil in one or more known locationsand orientations with respect to the external features of the patient(22) as well as with frame (26). The CARTO® 3 System byBiosense-Webster, Inc., of Diamond Bar, Calif., uses a system similar tothat described herein for finding the location and orientation of a coilin a region irradiated by magnetic fields.

In addition to registering with the external features of the patient(22), the registration of the present example further includesregistration with an image of the sinuses of the patient (22). In someinstances, this image of the sinuses of the patient (22) has beenacquired prior to a projected sinuplasty procedure. The preexistingimage of the sinuses of the patient (22) may comprise a CT (computerizedtomography) image, an MRI (magnetic resonance imaging) image, anultrasound image, a combination of such images, and/or one or moreimages captured using any other suitable imaging modality. It should beunderstood that, regardless of how the image of the sinuses of thepatient (22) has been acquired, frame (26) is in registration with boththe sinuses of the patient (22) and the external features of the patient(22) in the present example.

FIGS. 3A-3B show guidewire (28) of the present example in greaterdetail. Guidewire (28) comprises an outer coil (80) having an internallumen (82). By way of example only, coil (80) may be formed fromnon-ferromagnetic material, such as 316 stainless steel, titanium,cobalt-chrome, nitinol, MP35N steel alloy, and/or any other suitablematerials. In some versions, the nominal external and internal diametersof coil (80) are 0.9 mm and 0.6 mm respectively. Guidewire (28) has adistal end (30) and a proximal end (32).

A tapered nitinol core-wire (84) traverses the length of lumen (82).Core-wire (84) has a distal end (86) with a smaller outer diameter thanthe outer diameter of the proximal end (88) of core-wire (84). The taperof core-wire (84) may be formed by centerless grinding and/or any othersuitable technique(s). In some versions, a the outer diameter ofproximal end (32) is in a range of 0.25 mm to 0.35 mm; while the outerdiameter of distal end (86) is between 0.01 mm and 0.015 mm. Also insome versions, core-wire (84) has a length of approximately 10 cm.Core-wire (84) provides stability to the shape of guidewire (28) bybeing attached to outer coil (80) in at least two locations (e.g., bysoldering, etc.). With core-wire (84) attached to outer coil (80),core-wire (84) provides flexural and torsional characteristics toguidewire (28) that, inter alia, prevent guidewire (28) from “windingup” when the operator rotates proximal end (52). The superelasticity ofthe nitinol allows guidewire (28) to undergo considerable bending whilestill being able to return to its unbent state.

In addition to core-wire (84), an optic fiber (90) is inserted intolumen (82) so as to traverse the length of lumen (82). A distal end (92)of optic fiber (90) is configured to be in proximity to a transparentlens (96), which is connected to, and which acts as a distal terminationfor, outer coil (80). A lamp (not shown) or other light source iscoupled to a proximal end (98) of optic fiber (90) and is operated byprocessor (40) so as to illuminate lens (96) with visible light. Opticfiber (90) may comprise a single strand of fiber; or two or more strandsof optical fibers. By way of example only, optic fiber (90) may beformed of plastic or glass. In some versions, optic fiber (90) comprisestwo plastic strands each having a diameter of 250 microns. In some otherversions, optic fiber (90) comprises a single glass strand having adiameter of 150 microns or 200 microns.

Prior to insertion of optic fiber (90) into lumen (82), a magnetic fieldsensing coil (100) is wound around distal end (92) of optic fiber (90),so that after insertion into lumen (82), sensing coil (100) ispositioned at distal end (30) of guidewire (28). Sensing coil (100) thushas an internal diameter corresponding to the external diameter of opticfiber (90). In some versions, there is a small gap (e.g., approximately25 microns) between the internal circumference of sensing coil (100) andthe external circumference of optic fiber (90). In some versions,sensing coil (100) has an external diameter of 0.45 mm, although otherversions may have coil external diameters larger or smaller than 0.45mm. In the present example, the two ends of sensing coil (100) areconnected by conducting wires (104), which traverse the length of lumen(82). Conducting wires (104) are connected to circuitry in console (50),which is configured to enable processor (40) to measure and recordsignal levels generated by the two ends of sensing coil (100).Alternatively, the signal levels may be at least partially conveyedwirelessly to the circuitry in console (50).

FIGS. 4A-4B show an exemplary alternative guidewire (128). Guidewire(128) has a distal end (130) and a proximal end (132). Apart from thedifferences described below, the operation of guidewire (128) isgenerally similar to that of guidewire (28) (FIGS. 3A-3B), and elementsindicated by the same reference numerals in both guidewires (28, 128)are generally similar in construction and in operation. Thus, guidewire(128) may be used in place of guidewire (28) in system (20).

In contrast to guidewire (28), sensing coil (100) in guidewire (128) isnot wound around optic fiber (90). Sensing coil (100) is stillpositioned within lumen (82) at distal end (130) of guidewire (128).However, sensing coil (100) is separate from both core-wire (84) andoptic fiber (90) in this example. Signal levels from sensing coil (100)are transferred to circuitry, described above with reference to FIGS.3A-3B, enabling processor (40) to measure and record the signal levels.As is also described above, the transfer may be via wires (104) orwirelessly.

Guidewire (128) also comprises tapered core-wire (84), which extends thelength of lumen (82). As with guidewire (28), core-wire (84) acts tostabilize guidewire (128).

FIGS. 5A-5B show another exemplary alternative guidewire (228).Guidewire (228) has a distal end (230) and a proximal end (232). Apartfrom the differences described below, the operation of guidewire (228)is generally similar to that of guidewire (28) (FIGS. 3A-3B), andelements indicated by the same reference numerals in both guidewires(28, 228) are generally similar in construction and in operation. Thus,guidewire (228) may be used in place of guidewire (28) in system (20).

In guidewire (228), sensing coil (100) is configured to encircle distalend (86) of core-wire (84). An inside diameter of sensing coil (100) islarger than an external diameter of core-wire (84). Sensing coil (100)may be fixedly secured to core-wire (84) using any convenient means,such as epoxy cement, etc. Signal levels generated by sensing coil (100)are transferred to processor (40), substantially as described above forguidewires (28, 128). Some versions of guidewire (228) include an opticfiber, similar in functionality and characteristics to optic fiber (90),located in and traversing the length of lumen (82). Alternatively, asillustrated in FIGS. 5A-5B, guidewire (228) may simply lack optic fiber(90).

In an exemplary sinuplasty procedure, a guidewire such as guidewire (28,128, 228) is inserted into a nasal sinus. The circuitry coupled tosensing coil (100) acquires signals from sensing coil (100), while fieldgenerators (24) are transmitting their magnetic fields. Processor (40)applies the calibration relationship referred to above to the signals,and together with the registration also described above finds thelocation and orientation of sensing coil (100). An indication of thelocation and orientation of sensing coil (100), i.e., of distal end (30)of guidewire (28, 128, 228), may be overlaid onto a registered,preexisting image of the sinuses of the patient (22). The compositeimage, of the sinuses of the patient (22) and distal end (30) ofguidewire (28, 128, 228), may be displayed to physician (54) on screen(56) (FIG. 1). A more detailed description of such a use of a guidewire(28, 128, 228) in real-time surgery is provided with respect to theflowchart of FIG. 6, below.

FIG. 6 shows a flowchart of exemplary steps that may be taken usingsystem (20) to perform image guided nasal sinus surgery. In the presentexample, the surgery is assumed to be performed on the ostium andoutflow tract of a peripheral sinus, but those having ordinary skill inthe art will be able to adapt the description, mutatis mutandis, forother various types of sinus surgery. The steps of the flowchart of FIG.6 assume that the distal end (30) of guidewire (28, 128, 228) is trackedin real-time during the course of the surgery, by the magnetic trackingsystem described above. For clarity, in the flowchart descriptionhereinbelow guidewire (28) is assumed to be used, and those havingordinary skill in the art will be able to modify the description for theuse of other guidewires, such as guidewires (128, 228).

The distal tips of other instruments used during the surgery, such asthe distal tip of an endoscope, the distal tip of a guide catheter, thedistal tip of a dilation catheter, and/or other portions of suchinstruments and/or other kids of instruments, may also be tracked by themagnetic tracking system by incorporating respective coils into theinstrument distal tips for flexible or rigid instruments, as is known inthe art. Such instruments, which may typically be used for rhinologicalsurgery, including Functional Endoscopic Sinus Surgery (FESS) andballoon-assisted FESS, i.e., balloon sinuplasty, are commerciallyavailable.

It should therefore be understood that guidewires (28, 128, 228) arejust an illustrative example of an instrument that may incorporate asensing coil (100). Various other kinds of instruments that are used inENT procedures and that may readily incorporate a sensing coil (100)will be apparent to those of ordinary skill in the art in view of theteachings herein. It should also be understood that, for rigidinstruments, sensing coil (100) may alternatively be positioned in aproximal portion of the instrument, provided that the magnetic trackingsystem has been programmed to make the spatial adjustments required toconvert the signals received from sensing coil (100). Such a method fortracking is also known in the art.

In a preparatory step (300) a “raw” image of the anatomy to be operatedon is acquired. The raw image may comprise a CT image, an MRI image, ora US image, of the cranium. In some instances more than one such imageis combined and the composite image produced, after registration of thecombined images, is used as the raw image. Images are typically in aDigital Imaging and Communications in Medicine (DICOM) format. Ofcourse, any other suitable format may be used. Various suitable imagingmodalities, imaging systems, and image formats will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

In a first analysis step (302), the raw image is analyzed to isolatesino-nasal structures in the image. The analysis applies recognitionalgorithms to point clouds derived from the images so as to generate thedifferent structures. The algorithms are used to segment the image, andto form the segmented sections into three-dimensional (3D) structures.

By way of example only, the algorithms used during the analysis step(302) may be based on “seeded region growing” algorithms such as thosedescribed in the paper “Comparison of 3D Segmentation Algorithms forMedical Imaging,” by Hakan et al., published in the Twentieth IEEEInternational Symposium on Computer-Based Medical Systems, 2007, CBMS'07, which is incorporated herein by reference. Alternatively oradditionally, the recognition referred to herein may be implementedusing commercially available software, such as the OsiriX 6.5 imageprocessing software produced by Pixmeo of Bernex, Geneva, Switzerland,or the Mimics software produced by Materialise Inc. of Leuven, Belgium.Other suitable algorithms that may be used will be apparent to those ofordinary skill in the art in view of the teachings herein.

The points within the three-dimensional structures generated in thefirst analysis step (302) have coordinates that enable any givenstructure to be transformed. For example, a given structure may betranslated or rotated, or other types of transformation may be appliedto the structure.

In an image manipulation step (304), the three-dimensional structuresgenerated in step (302) are presented to the physician (54) on a screen,herein assumed by way of example to be screen (56). The physician (54)uses operating controls (51) to manipulate the image so that the regionto be operated on is clearly visible. To this end the physician (54) mayrotate, pan, and/or zoom the image, and/or generate one or morecross-sections of the image. In addition, the physician (54) may varythe transparency and/or color of the different structures. Themanipulation may include highlighting of a region that includes theregion to be operated on. For the outflow tracts considered here, suchhighlighting may conveniently be achieved by applying a sinus outflowtract recognition algorithm to the manipulated image. The recognitionmay use an algorithm similar to that referred to above in step (302),and/or may be implemented using the commercial software also referred toabove.

Other images that may be generated in step (304) include displays ofplanned surgical steps as described below, paths to be taken byinstruments as described below, and structures in proximity to theoutflow tracts.

Step (304) concludes an image preparation phase that is implementedprior to performance of the nasal sinus surgery. The following steps ofthe flowchart describe actions that may be taken during the surgery.

In an instrument preparation step (306), instruments to be used in thesurgery are prepared so that they can be tracked during the surgery. Theinstruments include guidewire (28), as described hereinabove, which canbe tracked by system (20) using sensing coil (100). The instruments mayalso include an endoscope, one or more flexible instruments, one or morecatheters, and/or any one or more of the following: grasping forceps,cutting forceps, including Blakesly forceps and Blakesly throughcuttingforceps, irrigation cannulae, suction cannulae, including Frazier andYankauer suction cannulae, balltipped probe, sinus seeker, Freerelevator, Coddle elevator, other elevators, J-curettes or othercurettes, punches, including mushroom punches, injection needles, needledrivers, monopolar or bipolar electrocautery probes, RF ablation probes,laser-energy transmitting probes, powered or manual microdebriders,shavers, drills, or burrs. Other suitable instruments will be apparentto those of ordinary skill in the art in view of the teachings herein.

As noted above, any such instruments may incorporate a sensing coil(100) to enable tracking of the positioning of the instrument. Suchsensing coils (100) may be configured to be tracked by system (20),using magnetic fields from field generators (24) to induce trackingsignals in sensing coils (100). Alternatively, the instruments mayinclude sensors that are configured to use the Hall effect to generatethe tracking signals. In the case of rigid instruments, the sensors maybe mounted on a proximal portion of the instrument in a known fixedspatial relation with the instrument distal portion. By way of exampleonly, a sensing coil (100) or other sensor may be mounted on or in thedistal portion of the instrument (e.g., particularly if the instrumentis flexible). In addition or in the alternative, a sensing coil (100) orother sensor may be mounted on or in the proximal portion of theinstrument (e.g., particularly if the instrument is rigid).

Regardless of where sensing coil (100) or other sensor is positioned,sensing coil (100) or other sensor may be built into an instrument atthe time of manufacture. In other instances, it may be desirable toattach one or more sensing coils (100) or other sensors to an instrumentprior to use of that instrument in surgery. A method for performing suchattachment is described in U.S. Pat. No. 8,190,389, entitled “Adapterfor Attaching Electromagnetic Image Guidance Components to a MedicalDevice,” issued May 29, 2012, the disclosure of which is incorporated byreference herein; and U.S. Pub. No. 2012/0245456, entitled “Adapter forAttaching Electromagnetic Image Guidance Components to a MedicalDevice,” published Sep. 27, 2012, the disclosure of which isincorporated by reference herein.

In a final real-time procedure step (308), the physician (54) activatesfield generators (24) to begin the instrument tracking process. Thephysician (54) also displays one or more images, in some instancesmultiple image panels, on screen (56). The images displayed may includethe real-time image formed by an endoscope used in the procedure, aswell as the images prepared and generated in step (304). It shouldtherefore be understood that the presentation of multiple image panelson screen (56) may enable the physician (54) to view several images fromdifferent sources simultaneously.

An indication of the location and orientation of the endoscope distalend may be overlaid, in registration, on the outflow tracts imagegenerated in step (304). Similarly, an indication of the location andorientation of the distal end (30) of guidewire (28) may also beoverlaid, in registration, with the outflow tracts image. As otherinstruments are introduced into the patient, their location andorientation may also be overlaid on the outflow tracts image.

The endoscope image referred to above may have superimposed upon it theimage of the outflow tracts generated in image manipulation step (304),as well as one or more images of other structures that may have beengenerated in the image manipulation step (304).

In some versions, the images displayed on screen (56) may be manipulatedby the physician (54) so as to improve the visibility of desiredportions of the image, and so as to reduce “noise” in the presentedimage. Such manipulation may include the physician being able to rendersections of the image (e.g., outer sections) to be at least partiallytransparent, so that inner sections of the image, including theindications of the distal tips of instruments used, including guidewire(28), are more visible. Alternatively or additionally, the manipulationmay include the physician applying “false” color to sections of theimage representing specific anatomical structures that have beensegmented in step (302). In some versions, the physician (54) usescontrols (51) to manipulate or adjust the images on screen (56). Inaddition or in the alternative, system (20) may be configured to enablethe physician (54) to manipulate or adjust the images on screen (56)using voice activation and/or other non-tactile methods of activation.

Because the location and orientation of distal end (30) of guidewire(28) are known in real-time, cross-sections or slices of the anatomy inproximity to distal end (30) of guidewire (28) may be generated anddisplayed on screen (56) by system (20). For example, a cross-section ofthe anatomy ahead of distal end (30) of guidewire (28) may be displayed.Other images that may be presented on screen (56) include displays ofplanned surgical steps, paths to be taken by instruments, and structuresin proximity to the structure being operated on. As stated above, suchimages are typically generated in image manipulation step (304). Furtherexamples of how such images may be generated and presented will bedescribed in greater detail below.

II. Exemplary Image Guided Surgical Tutorial

In some instances, it may be desirable to provide a physician (54) witha surgical plan or instructions on how to perform an ENT procedure(e.g., sinuplasty, etc.) on a patient (22), with such instructions beingcustomized based on the unique anatomy of that particular patient (22).As noted above with respect to manipulation step (304) shown in FIG. 6,processor (40) may be capable of manipulating image data associated withthe patient (22) to provide such instructions on images that depict theunique anatomy of the patient (22). Moreover, processor (40) may be ableto determine how best to perform the selected procedure on the patient(22) based on the unique anatomy of the patient, and may provide suchcustomized instructions via images generated during manipulation step(304). In addition or in the alternative, a physician (54) may providefurther input that is used to generate customized instructions viaimages generated during manipulation step (304).

Regardless of whether the instructional images are generatedautomatically and/or based on input from the physician (54), suchinstructional images may be provided in the form of a series of stillimages, a video “fly through,” and/or any other suitable form. Forshorthand purposes, the output will be referred to herein as“instructional images,” with it being understood that such images mayinclude still images, moving images (e.g., video, animations, etc.),combinations thereof, and/or any other suitable kinds of images. Itshould also be understood that instructional images may betwo-dimensional, three-dimensional, and/or combinations thereof.

Such instructional images may be rendered through one or more imagepanels on screen (56). Moreover, such instructional images may beautomatically updated as the physician (54) performs the procedure. Forinstance, system (20) may continuously track movement of instrumentsused by the physician (54), determine the stage of the procedure basedon such tracked movements, and update the instructional images based onthe current stage of the procedure. In addition or in the alternative,the physician (54) may provide input via controls (51), voiceactivation, and/or some other means to inform system (20) of the currentstage of the ENT procedure. Specific examples of how instructionalimages may be provided will be described in greater detail below. Itshould be understood that the following examples are merelyillustrative. Further examples and variations will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

A. Exemplary Process to Automatically Generate Customized Operation Plan

FIG. 7 shows an exemplary process that may be used to provide a surgicalplan for a physician (54), using data from system (20) and/or from othersources. It should be understood that the process of FIG. 7 may beincorporated into the process of FIG. 6. For instance, the process ofFIG. 7 may be performed as a subroutine within manipulation step (304)shown in FIG. 6. Alternatively, the process of FIG. 7 may be integratedinto some other larger process or may be performed as a stand-aloneprocess. The process of FIG. 7 will be discussed below as beingperformed by system (20), though it should be understood that theprocess of FIG. 7 may be performed by any other suitable system havingany other suitable components in any other suitable configuration. Byway of further example only, at least part of the process of FIG. 7 maybe performed through the system (1000) of FIG. 14 as described below. Itshould also be understood that part of the process of FIG. 7 may beperformed on one system, while another part of the process of FIG. 7 isperformed on another system.

At an initial step (400), a cranial image (or images) of the patient(22) is obtained. It should be understood that this is a cranial imageof the same patient (22) on whom the ENT surgical procedure will beperformed. This cranial image (or images) may be obtained using MRI, CT,and/or any other suitable imaging modality or modalities. At least someimage data may be created or supplemented by data provided through amapping process performed using system (20), where a probe having asensing coil (100) is maneuvered through the nasal cavity of the patient(22) to establish geometry of anatomical structures within the nasalcavity of the patient (22). In addition or in the alternative, the imagedata may be provided from another source (e.g., from scanning performedat some other time in the past and/or at some other facility, etc.).

In some instances, two or more images are provided in step (400). By wayof example only, the images may be provided as DICOM (Digital Imagingand Communications in Medicine) files and imported into processor (40).Processor (40) may include software that is specialized to evaluate thelayout of the anatomy of the nasal passages and paranasal sinuses basedon the images. In some examples, the images may comprise athree-dimensional image that is manipulable using a graphical userinterface. The three-dimensional image may be obtained by preparing asegmented three-dimensional model. In versions that employ use of athree-dimensional model, the three-dimensional model may be preexistingand thus imported into processor (40) as a three-dimensional model.Alternatively, processor (40) may generate the three-dimensional modelbased on two-dimensional image data that is imported into processor(40). Of course, any other suitable technique may be used to generatethe three-dimensional model. It should also be understood that someversions may not necessarily require the generation of a fullthree-dimensional model.

In the next step (402) of the process shown in FIG. 7, processor (40)receives an input from the physician (54) indicating the particular typeof procedure that the physician (54) wishes to perform on the patient(22). For instance, the physician (54) may provide this input usingoperating controls (51), using voice commands, and/or using any othersuitable form of input. System (20) may enable the physician (54) toselect from an extensive list of various ENT procedures, including butnot limited to dilation of the frontal recess, dilation of a maxillarysinus ostium, dilation of a sphenoid sinus ostium, dilation of aEustachian tube, formation of an opening in an ethmoid bulla, and/orvarious other ENT procedures. In some variations, processor (40) is onlyconfigured to provide a surgical plan for sinuplasty procedures, suchthat the physician (54) simply selects which passageway (e.g., thefrontal recess, the maxillary sinus ostium, the sphenoid sinus ostium,etc.) the sinuplasty procedure will be performed in.

Once system (20) has received the necessary image(s) (step (400)) thatare unique to the patient (22) at hand, as well as the input from thephysician (54) (step (402)) indicating the particular type of procedurethat the physician (54) wishes to perform on the patient (22), thesystem (20) may then perform an analysis step (404). During thisanalysis step (404), the software (e.g., as executed through processor(40)) evaluates the layout of the anatomy of the nasal passages andparanasal sinuses of the patient (22) based on the cranial image(s) thatwas/were imported as part of step (400) in relation to data associatedwith the medical procedure selected in step (402). It should beunderstood that the data associated with the various medical proceduresavailable for selection during step (402) may be stored locally insystem (20) and/or may be stored remotely on one or more remote servers,etc. Regardless of where such data is stored, processor (40) may accessand process the data associated with the medical procedure selected instep (402) and determine how to best implement that procedure on theunique anatomy of the patient (22) as represented by the cranialimage(s) that was/were imported as part of step (400). This processingmay include establishing a succession of translational and rotationalcoordinates with reference to the image(s) that was/were imported aspart of step (400).

Once processor (40) has completed the analysis step (404), processor(40) may generate an output to the physician (54) to thereby display anoperation plan (step (406)) that is tailored to the particular patient(22). The operation plan that is output at step (406) may provide a“roadmap” or step-by-step instructions to the physician (54) on how toperform the selected ENT procedure. By way of example only, when theselected ENT procedure comprises a sinus drainage passageway dilationprocedure, the operation plan that is output at step (406) may include aroadmap for performing at least some (if not all) of the following actson the patient (22): (i) positioning a guide member (e.g., guidecatheter, guide rail, guide probe, etc.) within the nasal cavity of thepatient, (ii) advancing a guidewire relative to the guide member toinsert the guidewire through a paranasal sinus drainage passageway(e.g., a paranasal sinus ostium, the frontal recess, etc.), (iii)advancing a dilator along the guidewire to position the dilator in theparanasal sinus drainage passageway, and (iv) expanding the dilator todilate the drainage passageway, to thereby enable ventilation anddrainage and restore normal outflow of mucus based on the naturaldirections of mucociliary transport. Of course, this is just one merelyillustrative example of an ENT procedure that may be the subject of anoperation plan that is output at step (406). Various other kinds of ENTprocedures that may be the subject of an operation plan that is outputat step (406) will be apparent to those of ordinary skill in the art inview of the teachings herein.

Various examples of how an operation plan may be visually displayed(step (406)) will be described in greater detail below with reference toFIGS. 9-13C. Other examples will be apparent to those of ordinary skillin the art in view of the teachings herein.

B. Exemplary Process to Manually Generate Customized Operation Plan

FIG. 8 shows another exemplary process that may be used to provide asurgical plan for a physician (54), using data from system (20) and/orfrom other sources. It should be understood that the process of FIG. 8may be incorporated into the process of FIG. 6. For instance, theprocess of FIG. 8 may be performed as a subroutine within manipulationstep (304) shown in FIG. 6. Alternatively, the process of FIG. 8 may beintegrated into some other larger process or may be performed as astand-alone process. The process of FIG. 8 will be discussed below asbeing performed by system (20), though it should be understood that theprocess of FIG. 8 may be performed by any other suitable system havingany other suitable components in any other suitable configuration. Byway of further example only, at least part of the process of FIG. 8 maybe performed through the system (1000) of FIG. 14 as described below. Itshould also be understood that part of the process of FIG. 8 may beperformed on one system, while another part of the process of FIG. 8 isperformed on another system.

As noted above with reference to the analysis step (404) of FIG. 7,system (20, 510) may include a database of stored ENT medical proceduresthat may be referenced in combination with the image(s) that was/wereimported as part of step (400). In the process of FIG. 8, such storedENT medical procedures may be initially created. In other words, theprocess shown in FIG. 8 may be performed without necessarily apre-existing database of stored ENT medical procedures. The process ofFIG. 8 may be performed by the physician (54) before the same physician(54) performs the ENT medical procedure on the patient (22). As anothermerely illustrative example, the process of FIG. 8 may be performed aspart of physician training, with a training physician (54) performingthe process of FIG. 8 while a trainee physician (54) carries out theoperation plan or instructions that are generated (step (406)) based onthe input that was provided by the training physician (54) during theprocess of FIG. 8.

At an initial step (500), a cranial image (or images) of the patient(22) is obtained. It should be understood that this is a cranial imageof the same patient (22) on whom the ENT surgical procedure will beperformed. This cranial image (or images) may be obtained using MRI, CT,and/or any other suitable imaging modality or modalities. At least someimage data may be created or supplemented by data provided through amapping process performed using system (20), where a probe having asensing coil (100) is maneuvered through the nasal cavity of the patient(22) to establish geometry of anatomical structures within the nasalcavity of the patient (22). In addition or in the alternative, the imagedata may be provided from another source (e.g., from scanning performedat some other time in the past and/or at some other facility, etc.).

In some instances, two or more images are provided in step (500). By wayof example only, the images may be provided as DICOM (Digital Imagingand Communications in Medicine) files and imported into processor (40).Processor (40) may include software that is specialized to evaluate thelayout of the anatomy of the nasal passages and paranasal sinuses basedon the images. In the present example, the software converts apointcloud into a segmented three-dimensional model (step (502)). Aspart of this process, the software applies sino-nasal structurerecognition algorithms through processor (40) (step (504)). The softwareultimately generates output in the form of a manipulatablethree-dimensional image (step (506)). Various suitable ways in whichsoftware may be configured to perform the above described steps (502,504, 506) will be apparent to those of ordinary skill in the art in viewof the teachings herein.

The physician (54) is then presented with a graphical user interface(GUI) to manipulate the three-dimensional image (step (508)). By way ofexample only, this GUI may enable the physician (54) to define atransparency and/or color for each anatomical structure as desired (step(510)). As one merely illustrative example, where the three-dimensionalimage is being prepared to provide an operation plan to dilate amaxillary sinus ostium, the physician may set a graphical representationof the uncinate process as being approximately 50% transparent; andcolor the maxillary sinus ostium red. The GUI may also enable thephysician (54) to provide various kinds of markings and/or annotationswithin the three-dimensional image. To facilitate exploration andmarking of the three-dimensional image, the GUI may further enable thephysician (54) to rotate, zoom, pan, tilt, take cross-sections, orotherwise alter two-dimensional views of the three-dimensional image(step (512)).

The software of the present example also provides visual highlighting ofoutflow tracts of the paranasal sinuses (step (514)). In the presentexample, this process is automated through the application of sinusoutflow tract recognition algorithms (step (516)). Various suitable waysin which software may be configured to perform the above described steps(508, 510, 512, 514, 516) will be apparent to those of ordinary skill inthe art in view of the teachings herein.

Once step (514) has been completed, processor (40) may generate anoutput to the physician (54) to thereby display an operation plan (step(406)). As noted above, the operation plan that is output at step (406)may provide a “roadmap” or step-by-step instructions to the physician(54) on how to perform the selected ENT procedure. By way of exampleonly, when the selected ENT procedure comprises a sinus drainagepassageway dilation procedure, the operation plan that is output at step(406) may include a roadmap for performing at least some (if not all) ofthe following acts on the patient (22): (i) positioning a guide member(e.g., guide catheter, guide rail, guide probe, etc.) within the nasalcavity of the patient, (ii) advancing a guidewire relative to the guidemember to insert the guidewire through a paranasal sinus drainagepassageway (e.g., a paranasal sinus ostium, the frontal recess, etc.),(iii) advancing a dilator along the guidewire to position the dilator inthe paranasal sinus drainage passageway, and (iv) expanding the dilatorto dilate the drainage passageway, to thereby enable ventilation anddrainage and restore normal outflow of mucus based on the naturaldirections of mucociliary transport. Of course, this is just one merelyillustrative example of an ENT procedure that may be the subject of anoperation plan that is output at step (406). Various other kinds of ENTprocedures that may be the subject of an operation plan that is outputat step (406) will be apparent to those of ordinary skill in the art inview of the teachings herein.

While not shown in FIG. 8, it should be understood that the software mayfurther enable the physician (54) to perform the ENT procedure virtuallyusing the three-dimensional image that was generated in step (506). Forinstance, the software may present the physician (54) with graphicalrepresentations of instruments that may be used in the ENT procedure,with such graphical representations of instruments being overlaid orotherwise integrated with the three-dimensional image. The physician(54) may manipulate the graphical representations of the instrumentsusing any suitable input or combinations of inputs (e.g., mouse,trackpad, keyboard, joystick, touchscreen, etc.). By allowing thephysician (54) to perform the ENT procedure virtually, the softwareenables the physician (54) to perform as many practice runs as desiredin order to assist the physician (54) in finding a most appropriatetechnique.

Moreover, data that is captured during the virtual ENT procedure may beused to develop the operation plan that is output at step (406). Inparticular, when the physician (54) has successfully completed one ormore steps of the virtual ENT procedure, the system may store themovements and orientations of the virtual instruments as manipulated bythe physician (54) during the virtual ENT procedure, and incorporate thestored successful movements and orientations of the virtual instrumentsin the operation plan that is output at step (406). In other words, thephysician (54) may first perfect the ENT procedure virtually on thethree-dimensional model of the patient's anatomy, then rely on theoperation plan that is output at step (406) in order to reenact themovements and orientations of the virtual instruments that weresuccessful in the virtual ENT procedure when the physician (54) usesreal instruments to perform the real ENT procedure on the patient (22).Various suitable ways in which the software may permit, capture, and usethe results of virtual ENT procedures will be apparent to those ofordinary skill in the art in view of the teachings herein.

C. Exemplary Process to Render a Customized Operation Plan

As noted above, the process shown in FIG. 7 and the process shown inFIG. 8 may each generate an output to the physician (54) to therebydisplay an operation plan (step (406)) that is tailored to theparticular patient (22). In the present example, the operation plan isprovided in the form of one or more instructional images. Theinstructional images that are displayed in step (406) may be renderedthrough one or more image panels on screen (56). FIG. 9 shows exemplarysteps that may be provided in conjunction with the operation plan thatis presented (step (406)) to the physician (54). Examples of the kindsof instructional images that may be displayed are described in greaterdetail below with reference to blocks (606, 608, 610, 612, 614) of FIG.9 and also with reference to FIGS. 10-13C.

In some instances, the ENT procedure may be performed with real visualguidance provided from an endoscope as shown in step (600). The videoview from the endoscope may be combined with one or more of theinstructional images that are displayed in step (406), such that theendoscopic view may be rendered through one or more image panels onscreen (56). The endoscope may further include a sensing coil (100) orother sensor, such that the position of the endoscope may be tracked bysystem (20). The positioning data from the sensing coil (100) or othersensor may be further incorporated into the one or more of theinstructional images that are displayed in step (406). For instance, agraphical representation of the endoscope may be superimposed orotherwise integrated into one or more virtual views of the sino-nasalanatomy of the patient as rendered through one or more image panels onscreen (56). This may provide the physician (54) with a better sense ofwhere the real-time position of the endoscope is within the nasalcavity, thereby providing a better context for the endoscopic view thatis being provided by the endoscope itself. In some other versions, theendoscope lacks a sensing coil (100) or other sensor, such that thesoftware presenting the instructional images does not depict orotherwise account for real-time positioning of the endoscope.

Similarly, the ENT procedure may be performed using one or moreinstruments that incorporate a sensing coil (100) or other sensor asdescribed above. In such instances, positioning data from the sensingcoil (100) or other sensor may be processed in conjunction with theoperation plan as shown in step (602). The positioning data from thesensing coil (100) or other sensor may be further incorporated into theone or more of the instructional images that are displayed in step(406). For instance, a graphical representation of the ENT instrumentmay be superimposed or otherwise integrated into one or more virtualviews of the sino-nasal anatomy of the patient as rendered through oneor more image panels on screen (56). This may provide the physician (54)with a better sense of where the real-time position of the ENTinstrument is within the nasal cavity, thereby supplementing the realendoscopic view of the ENT instrument. In some other versions, the ENTprocedure is performed without any of the ENT instruments having asensing coil (100) or other sensor, such that the software presentingthe instructional images does not depict or otherwise account forreal-time positioning of the ENT instruments.

Some versions may enable the physician (54) to manipulate theinstructional images before and/or during a surgical procedure. Forinstance, the software may enable the physician (54) to rotate, pan,tilt, zoom, explode, take cross-sections, and/or perform othermanipulations of the instructional images. This may enable the physician(54) to get a better sense of the precise positioning, orientation, anddirection of movement for the instrument at a given stage of a medicalprocedure. By way of example only, the physician (54) may manipulate theinstructional image using various kinds of inputs such as a mouse,trackpad, keyboard, joystick, touchscreen, etc. In addition or in thealternative, some versions may enable the physician (54) to manipulatethe instructional images using voice input (step (604)). This may keepboth of the physician's hands free to grasp and manipulate the endoscopeand other ENT instruments during the entire ENT procedure. Varioussuitable ways in which voice command capabilities may be incorporatedwill be apparent to those of ordinary skill in the art in view of theteachings herein.

Regardless of whether and how data/commands from steps (600, 602, 604)are used to influence the instructional images, it should be understoodthat the instructional images may take numerous different forms. Asnoted above, the instructional images that are displayed in step (406)may be rendered through one or more image panels on screen (56). Inother words, several instructional images may be presented to thephysician (54) simultaneously. When several instructional images arepresented to the physician (54) simultaneously, those severalinstructional images may provide views that are different from eachother. Various examples of forms that the instructional images may takeware described in greater detail below with reference to blocks (606,608, 610, 612, 614) of FIG. 9 and also with reference to FIGS. 10-13C.Any or all of the views described below with reference to blocks (606,608, 610, 612, 614) of FIG. 9 and also with reference to FIGS. 10-13Cmay be presented to the physician (54) simultaneously. It should beunderstood that the following examples are merely illustrative. Furtherexamples and variations will be apparent to those of ordinary skill inthe art in view of the teachings herein.

By way of example only, in versions where one of the ENT instrumentsincludes a sensing coil (100) or other sensor, one or more of theinstructional images may provide views of real-time triplanar CT slicesof the position of the tip of the ENT instrument, as shown in block(606). Various suitable ways in which an instructional image may depictthe real-time positioning of an instrument that has a sensing coil (100)or other sensor will be apparent to those of ordinary skill in the artin view of the teachings herein.

As also shown in FIG. 9, one of the instructional images may include adisplay of planned ENT procedure steps, instrument paths andorientations, and anatomical structures (block (608)). Further examplesof such a view will be described in greater detail below with referenceto FIGS. 10-13C.

In addition, as noted above, one of the image panels on screen (56) mayprovide a real endoscopic view of the nasal cavity from a real endoscope(block (610)), with the endoscopic view being provided adjacent to oneor more instructional images.

As another merely illustrative example, in versions where one of the ENTinstruments includes a sensing coil (100) or other sensor, one or moreof the instructional images may provide a real-time three-dimensionalmodel rendering showing the position of the tip of the ENT instrument,as shown in block (612). In some such versions, the visualrepresentations of the anatomical structures are shownsemi-transparently in order to prevent the visual representations of theanatomical structures from obscuring the view of the visualrepresentation of the ENT instrument. This view may further includecolor-identified anatomical structure segmenting and/or other visualfeatures that facilitate differentiation between different anatomicalstructures.

In versions that provide a real endoscopic view of the nasal cavity froma real endoscope, such a real endoscopic view may further includesoftware generated visual features that are superimposed or otherwiseintegrated into the real endoscopic view. For instance, the software maysuperimpose highlighting of the sinus outflow tracts (and/or othernotable anatomical structures) that are within the endoscopic field ofview (block (614)). Such an enhanced endoscopic view (block (614)) maybe provided in combination with or in lieu of a non-enhanced endoscopicview (block (610)).

FIG. 10 shows an example of one of the instructional images that may bedisplayed in step (406). In particular, FIG. 10 shows a superior axialcross-sectional view of anatomical structures in the nasal cavity of thepatient (22). In particular, FIG. 10 depicts the nasal septum (NS), themiddle turbinate (MT), the uncinate process (UP), and the ethmoid bulla(EB). It should be understood that this view would have been generatedfrom the cranial image(s) that were acquired in step (400) of theprocess shown in FIG. 7 or step (500) of the process shown in FIG. 8.The view of FIG. 10 also includes a set of arrows (700) that indicate apathway for insertion of an instrument into the maxillary sinus ostium(MSO). In some versions, the arrows (700) are all presentedsimultaneously and statically. In some other versions, the arrows (700)are animated to emphasize the directions of the pathway to the maxillarysinus ostium (MSO). In still other versions, a single arrow (700) isused, with the stem of single arrow bending along the tortuous path tothe maxillary sinus ostium (MSO). Other suitable ways in which across-sectional view may depict a path toward a maxillary sinus ostium(MSO) or other anatomical structure associated with the nasal cavitywill be apparent to those of ordinary skill in the art in view of theteachings herein. It should also be understood that several differentcross-sectional views (e.g., along different planes) may be presentedsimultaneously in order to provide the physician (54) with a bettersense of how the instrument path traverses three dimensions.

FIG. 11 shows an example of another one of the instructional images thatmay be displayed in step (406). In particular, FIG. 11 presents avirtual endoscopic view showing a graphical representation (800) of aguide catheter and a graphical representation (810) of a guidewire fromthe viewpoint of an endoscope whose line of sight is oriented toward themiddle meatus of the patient (22). The view thus shows the position andorientation of graphical representation (800) in relation to graphicalrepresentations of the nasal septum (NS), the middle turbinate (MT), theethmoid bulla (EB), and the uncinate process (UP). The view is providedwith a three-dimensional perspective in order to provide the physicianwith a better sense of how the guide catheter that is represented bygraphical representation (800) should be positioned relative to theanatomical structures.

In the example shown in FIG. 11, the instructional image is showing howto insert the guidewire into the maxillary sinus ostium. In a realendoscopic view of the same instruments and anatomy, the distal end ofthe guide catheter and the guidewire would be visually obscured by theuncinate process (UP). Thus, the instructional image depicts the distalend (804) of graphical representation (800) and graphical representation(810) in semi-transparent form; while depicting the proximal end (902)of graphical representation (800) in opaque form. The uncinate process(UP) is depicted in opaque form in this example. In another exemplaryvariation, the uncinate process (UP) is depicted in semi-transparentform. In such versions, the distal end (804) of graphical representation(800) and graphical representation (810) may be depicted in opaque form.Other suitable ways in which the instructional image may handle theobscuring of instruments by anatomical structures will be apparent tothose of ordinary skill in the art in view of the teachings herein.

In some versions, the instructional image of FIG. 11 is presented simplyas a still image. In some other versions, the instructional image ofFIG. 11 is provided as an animation. For instance, the instructionalimage may start by simply showing the anatomical structures. Theinstructional image may then show an animation of graphicalrepresentation (800) being moved into the position shown in FIG. 11. Theinstructional image may then show an animation of graphicalrepresentation (810) being moved into the position shown in FIG. 11.Other suitable ways in which the instructional image of FIG. 11 may beanimated will be apparent to those of ordinary skill in the art in viewof the teachings herein.

In some versions, the virtual endoscopic view of FIG. 11 is shownadjacent to a real endoscopic view of the same anatomical structures,such that the physician (54) may view both images together and move theactual guide catheter in a way such that the real endoscopic viewmatches the virtual endoscopic view. In versions where the endoscope andincludes a sensing coil (100) or other sensor, the virtual endoscopicview may be updated in real time to ensure that the line of sight forthe virtual endoscopic view matches (or at least closely approximates)the line of sight for the real endoscopic view.

In versions where the guide catheter and/or guidewire includes a sensingcoil (100) or other sensor, the virtual endoscopic view of FIG. 11 mayfurther include a superimposed graphical representation of the realguide catheter and/or the real guidewire. These superimposed graphicalrepresentations may be updated in real time. This may enable thephysician (54) to directly correlate the actual positioning of the realguide catheter with graphical representation (800); and the actualpositioning of the real guidewire with graphical representation (810).The physician (54) may thus move the real guide catheter and guidewireuntil the superimposed representations of the real guide catheter andguidewire overlap the corresponding graphical representations (800,810). In some such versions, the superimposed graphical representationof the real guide catheter and the real guidewire are provided insemi-transparent form; while graphical representations (800, 810) areprovided in opaque form. In some other versions, the superimposedgraphical representation of the real guide catheter and the realguidewire are provided in opaque form; while graphical representations(800, 810) are provided in semi-transparent form. Other suitable ways inwhich the actual positioning of one or more instruments may be displayedin real time in the same view as intended positioning of the one or moreinstruments will be apparent to those of ordinary skill in the art inview of the teachings herein. In some versions where system (20) istracking the positioning and movement of one or more of the instrumentsduring the surgical procedure, system (20) may provide an audible alertand/or a visual alert to the physician (54) to indicate when thephysician (54) has unacceptably deviated from the operation plan orinstructions. System (20) may also provide further instructions on whatthe physician (54) must do in order to get back on track with theoperation plan.

As another merely illustrative variation of the view shown in FIG. 11,the view may be provided as an enhanced, real endoscopic image. Forinstance, view may include a real depiction of the guide catheter, butsuperimpose one or more arrows and/or other directional indicators on ornear the real depiction of the guide catheter in order to indicate tothe physician (54) how the guide catheter should be oriented and moved.

FIG. 12 shows an example of another one of the instructional images thatmay be displayed in step (406). In particular, FIG. 12 presents avirtual endoscopic view showing a three-dimensional guide arrow (900)from the viewpoint of an endoscope whose line of sight is orientedtoward the middle meatus of the patient (22). The view thus shows theposition and orientation of guide arrow (900) in relation to graphicalrepresentations of the nasal septum (NS), the middle turbinate (MT), theethmoid bulla (EB), and the uncinate process (UP).

The three-dimensional configuration of guide arrow (900) provides thephysician with a sense of how the path of a guide catheter and guidewireshould traverse the three-dimensional space of the middle meatus to getaround the uncinate process (UP) and thereby reach the maxillary sinusostium (MSO). In particular, guide arrow (900) includes a proximalportion (902) presenting a proximal face (904); and a distal portion(906) presenting a conical tip (908). The inclusion and configuration offace (904) and tip (908) enable arrow (900) to visually convey aninstrument path through three-dimensional space more effectively than atwo-dimensional arrow would be able to. In addition, since guide arrow(900) traverses the space that is lateral to uncinate process (UP), theinstructional image depicts the distal end (906) of guide arrow (906) insemi-transparent form; while depicting the proximal end (902) of guidearrow (906) in opaque form. The uncinate process (UP) is depicted inopaque form in this example. In another exemplary variation, theuncinate process (UP) is depicted in semi-transparent form. In suchversions, the distal end (906) of guide arrow (900) may be depicted inopaque form. Other suitable ways in which the instructional image mayhandle the obscuring of instrument paths by anatomical structures willbe apparent to those of ordinary skill in the art in view of theteachings herein.

FIGS. 13A-13C show a series that may be depicted through another one ofthe instructional images that may be displayed in step (406). Inparticular, FIGS. 13A-13C present a virtual endoscopic view showing ananimated guide arrow (950) from the viewpoint of an endoscope whose lineof sight is oriented toward the middle meatus of the patient (22). Theview thus shows a moving representation of the path to be traversed byan instrument in relation to graphical representations of the nasalseptum (NS), the middle turbinate (MT), the ethmoid bulla (EB), and theuncinate process (UP). It should be understood that the instructionalimage may repeatedly cycle through sequence of the view of FIG. 13A,then the view of FIG. 13B, then the view of FIG. 13C, such that thephysician (54) may observe the movement of guide arrow (950) in order todetermine the appropriate path for the instrument. As shown in FIG. 13A,guide arrow (950) is solid. However, in FIGS. 13B-13C, guide arrow (950)is not solid. This transition from solid to non-solid indicates that thepath goes around the uncinate process (UP) to reach the maxillary sinusostium (MSO). Other suitable ways in which the movement of animatedguide arrow (950) behind an anatomical structure may be depicted will beapparent to those of ordinary skill in the art in view of the teachingsherein.

In addition or in the alternative to the foregoing, the instructionalimages may include textual annotations indicating how the instrumentshould be moved or otherwise manipulated. In addition or in thealternative, the instructional images may include a sequence of adjacentpanels showing the instrument at various stages of the procedure, suchthat the physician (54) may determine the appropriate path for theinstrument by viewing the image panels in a succession. In addition orin the alternative, the instructional images may include animation ofthe instrument to show how the instrument should be moved or otherwisemanipulated. As yet another merely illustrative example, screen (56) maydisplay a listing of textual instructions next to an instructionalimage, with the textual instructions providing step-by-step directionsto the physician (54) on where and how to manipulate the instrument inthe patient (22). Still other suitable ways in which instructionalimages may indicate the path for the instrument to follow will beapparent to those of ordinary skill in the art in view of the teachingsherein. It should also be understood that visual instructions may besubstituted or supplemented with automated voice instructions generatedfrom stored audio files, with the audio being played through a speaker,earpiece, or some other device that may be heard by the physician (54).

It should also be understood that, in addition to indicating the desiredpositioning, orientation, and direction of movement for the instrumentbeing used, the instructional images may call out certain anatomicallandmarks that may assist in providing a spatial context for thephysician (54). For instance, the instructional images may include textand an arrow to indicate the location of the middle turbinate (MT), textand an arrow to indicate the uncinate process (UP), text and an arrow toindicate a sinus ostium or other passageway, etc. Various suitable waysin which an instructional image may visually indicate one or moreanatomical landmarks will be apparent to those of ordinary skill in theart in view of the teachings herein. Similarly, various anatomicallandmarks that may be useful to indicate in an instructional image willbe apparent to those of ordinary skill in the art in view of theteachings herein.

In some versions, the instructional plan may identify several proceduralmilestones of the selected ENT procedure and rely on completion of thosemilestones in order to update the instructional images. For instance,for a sinuplasty procedure processor (40) may first provide one or moreinstructional images depicting proper placement of a guide catheterwithin the nasal cavity of the patient (22). Proper placement of theguide catheter may represent the completion of a first milestone, suchthat processor (40) may then provide a next set of instructional imagesdepicting proper placement of a guidewire after the guide catheter hasbeen properly placed. Proper placement of the guidewire may representthe completion of a second milestone, such that processor (40) may thenprovide a next set of instructional images depicting proper placement ofa dilation catheter after the guidewire has been properly placed. Properplacement of the dilation catheter may represent the completion of athird milestone, such that processor (40) may then provide a next set ofinstructional images depicting expansion of a dilator on the dilationcatheter after the dilation catheter has been properly placed.Subsequent and other milestones for a sinuplasty procedure will beapparent to those of ordinary skill in the art in view of the teachingsherein. Similarly, other suitable ways in which processor (40) may reactto completion of procedural milestones within a given surgical procedurewill be apparent to those of ordinary skill in the art in view of theteachings herein. Processor (40) may determine that a milestone has beencompleted based on positioning data from a sensing coil (100), based oninput from the physician (54), and/or based on any other suitableinput(s).

While several of the foregoing examples include the real-time trackingof the positioning of instrument an instrument (e.g., using one or moresensing coils (100)), it should be understood that such tracking is notrequired in all versions. Some versions may simply provide instructionalimages without performing any kind of tracking of instrument position ormovement. In such versions, processor (40) may advance through asequence of instructional images in response to input from the physician(54) (e.g., indicating completion of a milestone, etc.). Moreover, oncean operation plan has been generated (e.g., per step (406) of FIGS.7-9)), the ENT procedure may be performed without system (20) even beingpresent. For instance, the instructional images may simply be presentedvia a conventional monitor or screen, using a conventional PC or othercomputing device.

It should be understood from the foregoing that the use of instructionalimages as described above may enable the physician (54) to perform anENT procedure more safely and more efficiently. In particular, theinstructional images may eliminate or minimize the need to probe thesino-nasal anatomy of the patient (22) with a wire or other probinginstrument at the beginning of an ENT procedure. Eliminating orminimizing this need to probe may prevent unnecessary trauma toanatomical structures in the nasal cavity of the patient (22) andprovide faster surgery.

D. Exemplary System Arrangement

FIG. 14 shows components of an exemplary system (1000) that may be usedto generate a surgical plan as described above and preset a series ofinstructional images. It should be understood that system (1000) may beintegrated into console (100) shown in FIG. 1. Alternatively, system(1000) may be provided through separate hardware. As shown, system(1000) of this example comprises a central processing unit (CPU) (1012),a memory (514), an operating system (516) and a communication interface(I/O) (518). CPU (512) may include one or more single or multi coreconventional CPUs. One or more drivers (520) communicates with a device(not shown)) through a bus (522) or communications subsystem to whichthe device connects. Such drivers may run in user mode or kernel mode.CPU (512) executes control logic, involving operating system (516),applications (524), and driver (520,) to coordinate with the externalhardware devices.

Memory (514) may include command buffers (526) that are used by CPU(512) to send commands to other components of system (510). Memory (514)of this example contains process lists (528) and other processinformation such as process control blocks (530). Access to memory (514)can be managed by a memory controller (532), which is coupled to memory(514). For example, memory controller (532) may manage requests from CPU(512) and/or from other devices for access to memory (514).

System (510) of the present example further includes a memory managementunit (MMU) (534), which can operate in the context of the kernel oroutside the kernel in conjunction with other devices and functions forwhich memory management is required. MMU (1034) includes logic toperform such operations as virtual-to-physical address translation formemory page access. A translation lookaside buffer (TLB) (536) may beprovided to accelerate the memory translations. Operations of MMU (534)and other components of system (510) can result in interrupts producedby interrupt controller (538). Such interrupts may be processed byinterrupt handlers, for example, mediated by operating system (516) orby a software scheduler (SWS) (540). Of course, the foregoing componentsand arrangements of system (1000) are just merely illustrative examples.Other suitable components and arrangements that may be used to formsystem (1000) will be apparent to those of ordinary skill in the art inview of the teachings herein.

III. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

EXAMPLE 1

A method comprising: (a) receiving image data, wherein the image data isassociated with anatomical structures in a nasal cavity of a patient,wherein the image data is received through a computing system; (b)receiving surgical procedure data, wherein the surgical procedure datais received through a computing system; and (c) generating an operationplan, wherein the act of generating the operation plan is performedthrough a computing system, wherein the act of generating an operationplan comprises: (i) identifying a path for a surgical instrument inaccordance with the image data and in accordance with the surgicalprocedure data, and (ii) generating one or more instructional imagesdepicting the identified path for the surgical instrument in a depictionof anatomical structures in the nasal cavity of the patient.

EXAMPLE 2

The method of Example 1, wherein the image data comprises data from aplurality of CT images.

EXAMPLE 3

The method of any one or more of Examples 1 through 2, furthercomprising processing the image data to generate a three-dimensionalimage of anatomical structures in the nasal cavity of the patient.

EXAMPLE 4

The method of any one or more of Examples 1 through 3, wherein the oneor more instructional images include a three-dimensional image ofanatomical structures in the nasal cavity of the patient.

EXAMPLE 5

The method of Example 4, wherein the one or more instructional imagesfurther include a three-dimensional arrow indicating the identifiedsurgical instrument path in the three-dimensional image of anatomicalstructures in the nasal cavity of the patient.

EXAMPLE 6

The method of any one or more of Examples 1 through 5, wherein the actof receiving surgical procedure data comprises receiving inputindicating selection of a surgical procedure.

EXAMPLE 7

The method of Example 6, wherein the act of receiving surgical proceduredata further comprises retrieving surgical data from a database inaccordance with the received input indicating selection of a surgicalprocedure.

EXAMPLE 8

The method of any one or more of Examples 1 through 7, wherein the actof receiving surgical procedure data comprises receiving a selection ofa transparency level for one or more anatomical structures in the nasalcavity of the patient in at least one of the one or more instructionalimages.

EXAMPLE 9

The method of any one or more of Examples 1 through 8, wherein the actof receiving surgical procedure data comprises receiving a selection ofa field of view to be depicted in at least one of the one or moreinstructional images.

EXAMPLE 10

The method of any one or more of Examples 1 through 8, wherein the actof receiving surgical procedure data comprises receiving inputindicating a path for a surgical instrument relative to one or moreanatomical structures in the nasal cavity of the patient.

EXAMPLE 11

The method of any one or more of Examples 1 through 10, furthercomprising applying a sino-nasal structure recognition algorithm to thereceived image data.

EXAMPLE 12

The method of any one or more of Examples 1 through 11, furthercomprising manipulating the image data to highlight an outflow tractassociated with at least one paranasal sinus of the patient.

EXAMPLE 13

The method of any one or more of Examples 1 through 12, furthercomprising: (a) receiving an endoscopic video image from an endoscopeinserted into the nasal cavity of the patient; and (b) presenting theendoscopic video image while simultaneously presenting the one or moreinstructional images.

EXAMPLE 14

The method of Example 13, wherein the one or more instructional imagesand the endoscopic video image are presented simultaneously through asingle display screen.

EXAMPLE 15

The method of Example 14, wherein the one or more instructional imagesand the endoscopic video image are presented simultaneously throughseparate image panels of the same display screen.

EXAMPLE 16

The method of Example 13, wherein the act of presenting the endoscopicvideo image while simultaneously presenting the one or moreinstructional images comprises superimposing an instrument pathindicator on the endoscopic video image.

EXAMPLE 17

The method of any one or more of Examples 1 through 16, furthercomprising: (a) receiving position data from a position sensor of asurgical instrument; and (b) incorporating the position data into theone or more instructional images to depict actual positioning of thesurgical instrument in relation to planned positioning of the surgicalinstrument, wherein the planned positioning of the surgical instrumentis based on the identified path.

EXAMPLE 18

The method of any one or more of Examples 1 through 17, wherein at leastone of the one or more instructional images comprises a video image.

EXAMPLE 19

A method comprising: (a) receiving image data, wherein the image data isassociated with anatomical structures in a nasal cavity of a patient,wherein the image data is received through a computing system; (b)receiving surgical procedure data, wherein the surgical procedure datais received through a computing system; and (c) generating at least oneinstructional image identifying a path for a surgical instrument inaccordance with the image data and in accordance with the surgicalprocedure data, wherein the act of generating the at least oneinstructional image is performed through a computing system; wherein theat least one instructional image includes a representation of a surgicalinstrument positioned and oriented in accordance with the identifiedpath in a depiction of anatomical structures in the nasal cavity of thepatient.

EXAMPLE 20

A method comprising: (a) receiving image data, wherein the image data isassociated with anatomical structures in a nasal cavity of a patient,wherein the image data is received through a computing system; (b)receiving surgical procedure data, wherein the surgical procedure datais received through a computing system; and (c) generating at least oneinstructional image identifying a path for a surgical instrument inaccordance with the image data and in accordance with the surgicalprocedure data, wherein the act of generating the at least oneinstructional image is performed through a computing system; wherein theat least one instructional image shows a moving representation of asurgical instrument along the identified path in a depiction ofanatomical structures in the nasal cavity of the patient.

IV. Miscellaneous

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, versions of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a surgical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various versions of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometries, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I/We claim:
 1. A method comprising: (a) receiving image data, whereinthe image data is associated with anatomical structures in a nasalcavity of a patient, wherein the image data is received through acomputing system; (b) receiving surgical procedure data, wherein thesurgical procedure data is received through a computing system; and (c)generating an operation plan, wherein the act of generating theoperation plan is performed through a computing system, wherein the actof generating an operation plan comprises: (i) identifying a path for asurgical instrument in accordance with the image data and in accordancewith the surgical procedure data, and (ii) generating one or moreinstructional images depicting the identified path for the surgicalinstrument in a depiction of anatomical structures in the nasal cavityof the patient.
 2. The method of claim 1, wherein the image datacomprises data from a plurality of CT images.
 3. The method of claim 1,further comprising processing the image data to generate athree-dimensional image of anatomical structures in the nasal cavity ofthe patient.
 4. The method of claim 1, wherein the one or moreinstructional images include a three-dimensional image of anatomicalstructures in the nasal cavity of the patient.
 5. The method of claim 4,wherein the one or more instructional images further include athree-dimensional arrow indicating the identified surgical instrumentpath in the three-dimensional image of anatomical structures in thenasal cavity of the patient.
 6. The method of claim 1, wherein the actof receiving surgical procedure data comprises receiving inputindicating selection of a surgical procedure.
 7. The method of claim 6,wherein the act of receiving surgical procedure data further comprisesretrieving surgical data from a database in accordance with the receivedinput indicating selection of a surgical procedure.
 8. The method ofclaim 1, wherein the act of receiving surgical procedure data comprisesreceiving a selection of a transparency level for one or more anatomicalstructures in the nasal cavity of the patient in at least one of the oneor more instructional images.
 9. The method of claim 1, wherein the actof receiving surgical procedure data comprises receiving a selection ofa field of view to be depicted in at least one of the one or moreinstructional images.
 10. The method of claim 1, wherein the act ofreceiving surgical procedure data comprises receiving input indicating apath for a surgical instrument relative to one or more anatomicalstructures in the nasal cavity of the patient.
 11. The method of claim1, further comprising applying a sino-nasal structure recognitionalgorithm to the received image data.
 12. The method of claim 1, furthercomprising manipulating the image data to highlight an outflow tractassociated with at least one paranasal sinus of the patient.
 13. Themethod of claim 1, further comprising: (a) receiving an endoscopic videoimage from an endoscope inserted into the nasal cavity of the patient;and (b) presenting the endoscopic video image while simultaneouslypresenting the one or more instructional images.
 14. The method of claim13, wherein the one or more instructional images and the endoscopicvideo image are presented simultaneously through a single displayscreen.
 15. The method of claim 14, wherein the one or moreinstructional images and the endoscopic video image are presentedsimultaneously through separate image panels of the same display screen.16. The method of claim 13, wherein the act of presenting the endoscopicvideo image while simultaneously presenting the one or moreinstructional images comprises superimposing an instrument pathindicator on the endoscopic video image.
 17. The method of claim 1,further comprising: (a) receiving position data from a position sensorof a surgical instrument; and (b) incorporating the position data intothe one or more instructional images to depict actual positioning of thesurgical instrument in relation to planned positioning of the surgicalinstrument, wherein the planned positioning of the surgical instrumentis based on the identified path.
 18. The method of claim 1, wherein atleast one of the one or more instructional images comprises a videoimage.
 19. A method comprising: (a) receiving image data, wherein theimage data is associated with anatomical structures in a nasal cavity ofa patient, wherein the image data is received through a computingsystem; (b) receiving surgical procedure data, wherein the surgicalprocedure data is received through a computing system; and (c)generating at least one instructional image identifying a path for asurgical instrument in accordance with the image data and in accordancewith the surgical procedure data, wherein the act of generating the atleast one instructional image is performed through a computing system;wherein the at least one instructional image includes a representationof a surgical instrument positioned and oriented in accordance with theidentified path in a depiction of anatomical structures in the nasalcavity of the patient.
 20. A method comprising: (a) receiving imagedata, wherein the image data is associated with anatomical structures ina nasal cavity of a patient, wherein the image data is received througha computing system; (b) receiving surgical procedure data, wherein thesurgical procedure data is received through a computing system; and (c)generating at least one instructional image identifying a path for asurgical instrument in accordance with the image data and in accordancewith the surgical procedure data, wherein the act of generating the atleast one instructional image is performed through a computing system;wherein the at least one instructional image shows a movingrepresentation of a surgical instrument along the identified path in adepiction of anatomical structures in the nasal cavity of the patient.